As a leading notified body for MDD and IVD Directives, and certification and training body for ISO management systems certification, LRQA took part in the 5th China International Medical Device Regulatory Forum held from 26-29 August 2014 at International Conference Centre, Xiamen, China.
This year's event provided attendees with up-to-date information and resources from regulators and industry leaders that are necessary for anyone who wishes to meet the requirements for placing products onto the global market for medical devices.
Topics covered included China's new medical devices regulations, international medical devices regulations, technical method and medical device standards, conformity assessment and regulatory coordination covering the regulatory requirements in a number of countries.
LRQA's Industry expert Nick Baker, Technical Manager for IVD presented on a Notified Body view of the new IVD regulation. Download a copy of Nick's presentation slides below.
LRQA offers a range of Medical and In-Vitro Diagnostic Devices Directives services including:
- ISO 13485 Certification
- Conformity assessment under In-Vitro diagnostic devices directive
- Conformity assessment under Medical devices directive
- Training courses